CUFF Aortic Root Exposure Device MI-CUFF-001

GUDID 18022057015751

The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root and used to retract aortic wall tissue. The device consists of a main body component with retraction wings which are two-tiered and extend laterally. The posterior aspect of the device has a stabilization flange along the inferior border. Two alignment suture eyelet holes can be found within the medial portion of the stabilization flange.

CORCYM SRL

Aortic root retraction system
Primary Device ID18022057015751
NIH Device Record Key6b271e0c-5de3-486c-ade3-67392ade5e88
Commercial Distribution StatusIn Commercial Distribution
Brand NameCUFF Aortic Root Exposure Device
Version Model NumberMI-CUFF-001
Catalog NumberMI-CUFF-001
Company DUNS441454802
Company NameCORCYM SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108022057015754 [Primary]
GS118022057015751 [Package]
Contains: 08022057015754
Package: SHELF BOX [6 Units]
In Commercial Distribution

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-11
Device Publish Date2026-02-03

Devices Manufactured by CORCYM SRL

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18022057015751 - CUFF Aortic Root Exposure Device2026-02-11 The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root an
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